IAJPS 2017, 4 (12), 4253-4264 Muhammad Saood et al ISSN 2349-7750

CODEN [USA]: IAJPBB ISSN: 2349-7750

INDO AMERICAN JOURNAL OF

PHARMACEUTICAL SCIENCES
http://doi.org/10.5281/zenodo.1095491

Available online at: http://www.iajps.com Research Article

QUALITY CONTROL ANALYSIS AND ASSESSMENT OF

DIFFERENT MARKET BRANDS OF CIPROFLOXACIN
Ejaz Agha1*, Haroon Khan2, Nisar Ahmed1, Ghulam Murtaza1, Ashiq Hussain3,
Muhammad Saood1
1
Faculty of Pharmacy and Health Sciences University of Balochistan Quetta.
2
Gomal University, Dera Ismail Khan, Pakistan
3
Bolan Medical College Quetta.
Abstract:
Dose structures are basically pharmaceutical items in the structure in which they are showcased for use, normally
including a blend of dynamic medication parts and nondrug segments (excipients), alongside other non-reusable
material that may not be considered either fixing or bundling, (for example, a container shell, for instance). The
term unit measurements can now and then envelop non-reusable bundling too (particularly when every medication
item is exclusively packaged. Different measurements structures might exist for a solitary specific medication, since
various medicinal conditions can warrant distinctive courses of organization. For instance, steady queasiness and
heaving might make it hard to utilize an oral dose structure, and in such a case, it might be important to use a
backup course of action, for example, inhalational, buccal, sublingual, nasal, suppository or parenteral. The
primary objective was in vitro comparative study of 5 different brands of Ciprofloxacin Tablets available in markets
of Pakistan by The in vitro comparative study of 5 different brands of Ciprofloxacin Tablets available in markets of
Pakistan
Weight variation Test, Disintegration Test, Hardness Test, Chemical Assay and In vitro dissolution study was
conducted. After conducting color, friability, weight variation, hardness test and disintegration tests of various
brands of Ciprofloxacin, the results were found under the acceptance range. The hardness showed variation among
the tablets of various brands but there was no significant variation of hardness among the tablets of same brand.
The Axcin indicated maximum drug potency (102%) and (101%) respectively while minimum potency was 93.07%.
The in-vitro evaluation of 5 different F.P.Ps of Ciprofloxacin HCl film coated tablets available in the
pharmaceutical market of Pakistan showed that all of brands of Ciprofloxacin satisfied the USP potency
specifications and showed evidences of satisfactory initial in-vitro dissolution behavior.
Corresponding author:
Muhammad Saood, QR code
Faculty of Pharmacy and Health Sciences,
University of Balochistan,
Quetta.
E-mail: saoodsky8@gmail.com)

Please cite this article in press as Muhammad Saood et al., Quality Control Analysis and Assessment of Different
Market Brands of Ciprofloxacin, Indo Am. J. P. Sci, 2017; 4(12).

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 IAJPS 2017, 4 (12), 4253-4264 Muhammad Saood et al
INTRODUCTION:
The generic drugs are made available to
health care system in many developing
countries [1] Thats to improve the
healthcare drug availability and delivery in
developing countries but in addition to
benefits it also accompanied by a lot of
issues among which substandard drugs
distribution in crucial one [2]. The drugs
monitoring includes all procedures
performed in obtaining relatively more and
more data regarding product after it has got
authorization for marketing and made
publicly available for use and these that
gotten from different procedures can be used
for making standards [3], regulations and for
improvement in product [2]. As the
regulatory authorities depends upon limited
information that are obtained from trials
(clinical) and from other literatures for
allowing and it is very important to monitor
the medicines (approved) for its therapeutic
effectiveness and Quality of medicines that
are used by large population [4]. The
medication significance in increasing patient
satisfaction and lowering mortality may not
be overemphasized like as low-quality
medicines are relatively unsafe and also
increase in treatment cost due to the
medication having low quality [5].
Therefore, testing the drugs in laboratory in
routine basis is important to save health of
public especially in countries that are
developing. World Health organization has
already issued guidelines for requirements,
quality control and registration of generic
drugs [6]. The innovator drugs efficacy,
safety and quality standards must also be
satisfied by generic drugs [2]. Poor practices
of quality control and concerned regulatory
authorities has allowed presence of low
Quality medicines in market [7]. It may have
many causes as decomposition of main
ingredient from drug due to storage
conditions like humidity and temperature
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and also poor quality assurance during drug
manufacturing [8].
The objective of present study was analysis
of Quality control and to assess different
brands of Ciprofloxacin that are available in
market.
MATERIAL AND METHODS:
Five different brands of ciprofloxacin HCl
(Axcin, Mytil, Nafcin, Oxirase And Quash)
film coated tablets in which one brand is
innovator (Axcin) and other four brands are
generics, each of 500 mg available in
Pakistani pharmaceutical market were
evaluated.
UV-Visible Spectrophotometer (Model No.
1601, Schimadzu, Japan), Mosanto tablet
hardness tester (Mosanto UK), Erweka
disintegrating chamber, Orion Research
analogue pH meter model 301, Siliconizad
glass test tubes, Digital analytical balance
(Model No. Ax-200. Schimadzu Japan.),
Volumetric flasks, Conical flasks, glass
funnels, test tubes (Pyer glass, scott), Sterile
(pyrogen free disposable syringes(Otsuka),
Pharma Test Dissolution Apparatus, PTWS
11/P, TPT (Germany), Stability Chamber,
Oven Memert Model U-30, 854 Schwabach
(Germany).
Weight variation and disintegration test
Twenty tablets of each brand were weighed
individually and calculated the average
weight of tablet. Maximum and minimum
values for weight were noted. USP limits for
weight variation test were applied to
evaluate the data.
USP specifications were applied for
disintegration test with a constant frequency
(speed) rate 32 c.p.m (speed limit is 29-32
c.p.m as per USP specification) at
temperature of 37 C. (Temperature limit is
35 C -39 Cas per USP specifications). As
the disintegration test was carried out for the
film-coated tablets so it was performed in
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 IAJPS 2017, 4 (12), 4253-4264 Muhammad Saood et al
two steps using following two different
Medias.
1. Water: The tablets were first immersed in
water for five minutes prior to disintegration
to dissolve the film coat of the tablets.
2. 0.1 N HCl: After dissolving the coat of
the tablet, it was placed in the disintegration
apparatus using 0.1 N HCl as disintegration
medium. Six tablets of each brand of
Ciprofloxacin and were taken and the mean
disintegration time (in minutes) was
calculated. If the test was failed for these
first six tablets then the test was performed
for other twelve tablets of each brand of
Ciprofloxacin in two rounds, six tablets in
each round. USP tolerance was applied to
evaluate the results obtained.
Hardness Test/Crushing Strength:
Twenty tablets of each brand were selected
randomly and subjected to hardness test.
The range of crushing strength was noted.
The instrument showed the force of breaking
in Newton, which were converted in
Kg/cm2. After that the results obtained were
evaluated using USP tolerance limits.
Chemical Assay of Ciprofloxacin Tablets:
The assay for the active ingredients in the
Ciprofloxacin HCl film coated tablets was
performed using UV-Visible
spectrophotometer. The chemical assays
were repeated three times and results are
presented as the mean of three
determinations.
Standard Preparation: Weight of the
Ciprofloxacin HCl equivalent to 100 mg of
Ciprofloxacin base were calculated as
follow,
= Molecular Weight of Ciprofloxacin
Monohydric chloride Monohydrate 100
Molecular weight of Ciprofloxacin base
So, 116.4 mg of Ciprofloxacin HCl
equivalent to 100 mg of Ciprofloxacin base
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were calculated and were used during
standard solution preparation for assay of
the tablets.
The calculations were made on the basis of
weight of Ciprofloxacin HCl equivalent to
Ciprofloxacin base.
Powder of standard Ciprofloxacin HCl
equivalent to 100 mg of Ciprofloxacin base
were weighed accurately with the help of
electronic balance. This amount of powder
of respected drugs was transferred to 100 ml
of volumetric flask in which small amount
of 0.1 N HCl was added to dissolve
Ciprofloxacin HCl powder. It was sonicated
well for 20 minutes to get clear solution.
The volume was made upto 100 ml with 0.1
N HCl in the volumetric flask and was
mixed.
Sample Preparation: Twenty tablets of
Ciprofloxacin 500mg were taken and
crushed into powder form. Then these
powders were sieved through 100 mesh and
weighed accurately with the help of digital
electronic balance .Average weight for a
single tablet was determined by dividing the
total weight of sieved powder by total
number of tablets.
Weight for a single tablet equivalent to
100mg of active Ciprofloxacin was
calculated as follows.
Equivalent weight of tablet of Ciprofloxacin =
Average weight of single tablet 100
Total weight of active ingredient in tablet
Now powder equivalent to 100 mg of active
(Ciprofloxacin as base) were weighed and
taken in 100ml volumetric flask and then a
small quantity of 0.1 N HCl solution was
added to dissolve the given quantity of
powder. After that the volume was made up
to mark by adding 0.1 N HCl solution. The
solution was stirred for 20 minutes to
dissolve and mixed it completely. This
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 IAJPS 2017, 4 (12), 4253-4264 Muhammad Saood et al
solution was filtered in conical flask. One ml
of filtrate was taken in a 100 ml volumetric
flask.
Analysis: Absorbance of sample solution
and standard solution were measured at
max.276nm on UV-Visible
Spectrophotometer using 0.1 N HCl as
blank.
In vitro dissolution study:
Dissolution of tablets of Ciprofloxacin were
carried in the following two Medias.
1. Distilled Water
2. 0.1 N HCl Solution
0.1 N HCl was also used as a dissolution
medium for dissolution tests to determine the
influence of tropical climate storage conditions
on the quality of tablets which is a major part of
my current project.
Calibration curve for Ciprofloxacin HCl in
Distilled water: forty mg of standard grade
Ciprofloxacin HCl powder were accurately
weighed with the help of digital electronic
balance and after weighing transferred to 100 ml
volumetric flasks. It was dissolved in small
quantity of distilled water and then sonicated for
20 minutes to get a stock clear solution .This
solution was diluted with addition of distilled
water in sufficient quantity to make the volume
up to the mark. So aqueous solution of
Ciprofloxacin having 0.4 mg/ml concentration
was prepared which was used as stock solution
.Different volumes of stock solution were taken
in 100 ml flask and each volume this solution
was diluted by making the volume up to 100 ml
with corresponding dissolution medium
(Distilled water) to get solutions of
Ciprofloxacin HCl of 0.008, 0.01, 0.012, 0.014,
0.016, 0.018 and 0.02 mg/ml. These solutions
were analyzed with UV-Visible
Spectrophotometer at max 276nm while using
distilled water as blank solution. Three readings
were noticed for each dilution and mean of these
three readings was calculated for the respective
concentration. A calibration curve was
constructed by plotting absorbance versus
concentrations which gave an equation of y=
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87.597-0.0079 with coefficient of variation
(R2) of 0.9999 (n=7).
Calibration curve for Ciprofloxacin HCl in
0.1 N HCl: Calibration curve for Ciprofloxacin
HCl was also constructed in 0.1 N HCl solutions
by following the same procedure
As described above for calibration curve of
Ciprofloxacin HCl in Distilled Water except
0.1N HCl was used as solvent in this case. The
equation obtained was y= 122.49 +0.0004 with
a coefficient of variation (R2) 0.9997 in this
case. Unknown concentrations of Ciprofloxacin
HCl were determined using regression equation.
Y=MC+B
Where Y= absorbance of solution containing
Ciprofloxacin HCl at max 276nm.
M= Slope of Ciprofloxacin HCl Standard curve
of Known concentrations.
C= concentration to Calculate
B= Intercept of curve
After rearranging the above equation we got:
C= (Y-B)/M
Dissolution tests for Ciprofloxacin HCl were
performed using the USP paddle method
(Apparatus II) at speed of 50rpm. The volume of
dissolution medium in each vessel was 900 ml,
maintained at a temperature of 37.0 0.5 C.
Aliquots (5ml) of the dissolution medium were
withdrawn at interval of 5,15,30,45 and 60
minutes. The samples were withdrawn manually
using a 5ml syringe from each vessel of the
dissolution apparatus. After each sampling equal
volume of dissolution medium was added to
each vessel as replacement solution. The
dissolution samples were diluted with the
dissolution medium (1:50) so as to get
absorbance in the linear range of the Lambert-
Beer Law and were analyzed by UV-Visible
spectrophotometer at max 276nm. After
calculating the results for dissolution profiles of
the finished pharmaceutical products of
Ciprofloxacin in both of the dissolution media
(D/W and 0.1 N HCl) these were also compared
with each other.
Statistical Calculation: The profiles of
formulations that met these requirements were
further evaluated using Weilbur function
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 IAJPS 2017, 4 (12), 4253-4264 Muhammad Saood et al
models, a Model Independent Approach using a
Similarity Factor (f2) as recommended by the
FDA for the comparison of the dissolution
profiles of immediate release dosage forms .[87]
In this study ,the dissolution profile of the test
formulation obtained was compared with the
dissolution characteristics of the reference
formulation *(innovator brand Axcin) obtained.
As the dissolution studies were performed in two
different media hence the f2 was calculated for
the tablet dissolution profiles in both media. The
f2 values thus obtained from dissolution in D/W
was compared with obtained from the tablet
dissolution in 0.1 N HCl to determine the
similarity of their dissolution behavior in the
corresponding medium .The similarity factor
was computed using the equation by Moore and
Flanner recommended by the FDA(51).
Where Rt and Tt are the percentages of drug
dissolved at time t (for t=1, 2, ..n), of the
reference and test formulation respectively. The
measurements at each time point were weighed
according to its importance in the dissolution
curve using wt as an optional weight factor. As
all time points were equal so wt was assigned
value 1. The profiles of F.P.Ps were considered
similar/pharmaceutically equivalent showing
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less than 10% average difference at any sample
time point, corresponding to a similarity factor
(f2) greater or equal to 50.
RESULTS AND DISCUSSION:
Table 1. Shows the results of quality control
tests of all the selected brands of finished
pharmaceutical products Ciprofloxacin.
After conducting colour, friability, weight
variation, hardness test and disintegration
tests of various brands of Ciprofloxacin, the
results were found under the acceptance
range. The hardness showed variation
among the tablets of various brands but
there was no significant variation of
hardness among the tablets of same brand.
The maximum hardness was observed for
MYTIL While NAFCIN Showed minimum
hardness among all the formulations of
Ciprofloxacin. The disintegration time test
showed appreciable differences for different
brands of Ciprofloxacin. No co-relation was
observed between hardness and
disintegration time of the formulations. The
divergence in the hardness, weight and
disintegration time test values may due to
differences in the manufacturing procedure
or in the quantity and quality of the
materials used in the formulations.
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Table: 1- Quality control tests of Five F.P.Ps of Ciprofloxacin

Room temperature
F.P.P Time Colour Hardness Friability Weight variation Disintegration assay
0 month White 8.4 0.1 740.98 10 102.320%
AXCIN 3 month White 8.4 0.1 740.70 10 101.200
6 month White 8.3 0.1 739.70 10 100.127
0 month White 5.4 0.4 803.10 12 100.789
MYTIL
3 month White 5.2 0.4 802.92 12 100.140
6 month White 5.1 0.4 802.95 13 99.124
0 month White 10.17 0.31 780.75 18 97.281
NAFCIN
3 month White 10.2 0.39 779.95 18 96.200
6 month White 10.4 0.38 779.40 19 96.142
0 month White 7.9 0.53 723.16 11 99.035
OXIRASE 3 month White 7.4 0.54 722.75 11 98.765
6 month White 7.3 0.55 721.62 12 97.576
0 month White 6.53 0.42 777.52 25 96.930
QUASH 3 month White 6.43 0.40 780.08 25 96.132
6 month White 6.21 0.43 775.65 25 95.768
Accelerated Temperature

FPP TIME Color Hardness Friability Weight variation disintegration Assay

0 month White 8.37 0.1 740.70 10 101.920%
AXCIN
3 month White 8.23 0.1 740.40 10 101.143
6 month White 8.20 0.1 740.34 10 100.045
0 month White 5.36 0.38 801.65 12 99.978
MYTIL
3 month White 4.95 0.37 801.80 12 99.041
6 month White 4.90 0.36 801.25 13 98.980
0 month White 10.1 0.3 775.54 19 97.045
NAFCIN
3 month White 10.3 0.29 774.87 20 96.013
6 month White 10.27 0.27 774.25 25 95.897
0 month White 7.6 0.57 721.65 11 98.934
OXIRASE 3 month White 7.2 0.58 720.54 12 98.254
6 month White 7.19 0.52 720.20 12 97.890
0 month White 6.6 0.39 772.65 25 96.340
QUASH 3 month White 6.36 0.42 773.54 26 96.043
6 month White 6.25 0.42 773.20 26 95.740

Table: 2 was 93.07% which was shown by

Table 2 describes the results of the drug potency
of different brands of Ciprofloxacin. All the
selected brands met USP 24 requirements in
spite of the appreciable differences among the %
drug potency of various formulations. The Axcin
indicated maximum drug potency (102%) and
(101%) respectively while minimum potency
OXIRASE.The differences among the results
showing the the drug potency may be due to the
following reasons.
(a) Manufacturing process variations.
(b) Use of various quality and quantity
of formulation materials and
(c) Use of poor quality of raw materials

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Table 2: Chemical Assay of Ciprofloxacin tablets

FPP Absorbance (Mean)
Sample Standard %Q

Axcin 1.178 1.17 102.320

MYTIL
1.105 1.17 96.134
NAFCIN
1.116 1.17 97.865
OXIRASE
1.061 1.17 93.07
QUASH 1.129 1.17 99.03

Table 3 And Fig 1 to 3 show the results of
the calibration curves of Ciprofloxacin HCl
in D/W and in 0.1 N HCl. A prominent
difference in the dissolution and solubility of
Ciprofloxacin in D/W and 0.1 N HCl is
obvious from the comparison of both the
calibration curves, obtained from analysis of
the similar concentrations of Ciprofloxacin
HCl in D/W and in 0.1 N HCl solvents
under similar conditions. Greater absorbance
was observed for the concentration of
Ciprofloxacin in 0.1 N HCl (solvent) as
compared to the absorbance of the same
concentration in D/W at same max
(276nm).this confirms that dissolution and
solubility of Ciprofloxacin in 0.1 N HCl (at
pH 1.2) is greater than D/W. This difference
was also demonstrated by the dissolution
profiles of selected brands of Ciprofloxacin
HCl in both the dissolution media (D/W and
0.1 N HCl

Table 3: Conc. Vs peak areas of Ciprofloxacin in D/W and 0.1N HCl

Sr.# Stock Dilutions Absorbance in D/W Absorbance

Soln(ml) mg/ml In 0.1N HCl
1 2.0 0.008 0.686 0.980
2 2.5 0.010 0.863 1.218
3 3 0.012 1.040 1.470
4 3.5 0.014 1.217 1.708
5 4 0.016 1.394 1.991
6 4.5 0.018 1.572 2.208
7 5 0.020 1.749 2.432

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Fig.1: Calibration curve of Ciprofloxacin HCl in D/W

Fig.2: Calibration curve of Ciprofloxacin HCl in 0.1N HCl

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Fig.3: Comparison b/w calibration curves of Ciprofloxacin HCl in D/W and 0.1 N HCl.

The table 4 shows the results of the comparative
dissolution of individual brands of Ciprofloxacin
in D/W and 0.1 N HCl. All the formulations
dissolution profiles were found within the USP
24 recommended range, in both the dissolution
media with discernible variations among their
profiles. Dissimilarity among the different
formulations dissolution profiles within the
same dissolution media were found. Two of the
Five (40% sampled) brands of Ciprofloxacin
(Axcin, Mytil,) and one out of the Five (20%
sampled) brands showed very rapidly dissolving
immediate release profile by exhibiting >85%
drug release within first 15 minutes in 0.1 N HCl
while this was accomplished by one of Five
(20%) brands of Ciprofloxacin (Axcin) in D/W.
All other formulations of v showed
comparatively weak dissolution profile.

Table 4: Dissolution Data of Axcin at room temperature

DW
0 month 3 month 6 month
5 min 71.3719 71.3809 71.7645
15 min 79.8957 80.9431 81.0321
30 min 95.1005 95.2410 95.8965
45 min 95.2053 95.8954 95.9785
60 min 95.0717 95.9732 96.0132
0.1 HCl
0 month 3 month 6 month
5 min 80.8935 80.9785 81.0216
15 min 88.9758 89.0214 89.1340
30 min 97.4255 97.6532 97.7543
45 min 97.9643 97.9865 98.0021
60 min 97.6049 98.0145 98.1325

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The disintegration profiles acquired from all
brands after capacity at mimicked tropical
conditions were found inside of the USP
prescribed reach for in-vitro drug discharge
.Moreover all the F.P.Ps showed a checked
lessening with abnormal state of varieties among
their in-vitro drug discharge profiles amid
capacity at recreated tropical conditions. Which
clarify the estimations of f2 for the
disintegration information of individual brands
furthermore indicate examination among the
closeness component (f2) of chose definitions at
3 months and 6 months at reenacted tropical
capacity conditions. The f2 values computed for
Mytil, Nafacin and OXIRASE were 67.2, 65.3,
62.95 individually following 3 and 6 months
stockpiling showing noticeable similitude in
their disintegration profiles with the standard
medication.Therefore disintegration qualities of
these plans were considered pharmaceutically
proportionate medication discharge profiles of
standard medication (87).
After capacity at reproduced tropical conditions
for 6 months under both conditions, all plans
demonstrated similitude (f2 >50) in the
disintegration profile with that of the standard
medication Axcin. The base contrast in the profile
were watched for Oxrase (f2=36.61) individually.
In addition, the varieties in the profile were an
excess of higher after capacity at 40 C 2
RH:75%5% when contrasted with that of the
outcomes after capacity at 25 C 2C/RH :60%
5% for 6 months. It unmistakably clarifies the
more conspicuous impact of expansion
temperature and relative stickiness amount in
nature upon the soundness of the Ciprofloxacin
(88).
As it has been seen by Pecol et al. in 1999(89)
that the nature of medications turns out to be less
sure especially for poor populaces why should
charmed lower evaluated drugs in an unregulated
situation .For this situation, it is imperative that
the medication administrative power ought to take
the fundamental measure to guarantee that the
medications accessible in the pharma business
sector are persistently of good quality. The
substance examine results on the substance of the
API outlined this point of confinement was inside
of the procurement prescribed by the USP for all
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F.P.Ps. The discoveries are like those delivered
Abdi et al. in 1995 (90) on the nature of
chloroquine tablets accessible on the pharma
business sector of Tanzania, where all inspected
F.P.Ps from 10 distinct makers were found inside
of the scope of USP particulars of the concoction
examine test. However a report was presented by
Kibwage et al. in 1992 (91) delineated that
roughly 45% of all the F.P.Ps inspected from the
pharmaceutical business sector of Kenyan and
dissected at the quality control lab of Daru were
found of substandard quality as far as the
substance of the API. Additionally another study
was led by Shakoor et al. in 1997 (92) pointed on
the vicinity of both fake and substandard
medications on the pharma markets of Thai and
Nigerai where 32 % of 89 tests did not go along
the USP details of synthetic examine. These
varieties in results can't be explained, taking into
account the continuance of a fruitful medication
control and observing framework. As it has been
seen in numerous reports concerning the nature of
medications in the creating nations. (93)
A few studies have been portrayed in the writing
audit on the soundness of the pharmaceutical
measurement shapes under honest to goodness
stockpiling environment in the tropics (94, 95,
96). Every one of these reports have pointed on
the substance strength of the medication. It is
perceived that under states of hot moist
temperature, the API might encounter
polymorphic or precious stone changes, which
reduce its characteristic solvency. In addition,
there is probability of collaborations between
excipient-excipient or excipient-drug connections
to happen affected by hot sticky temperature,
which understudy diminish the disintegration rate
of a pharmaceutical dose shapes containing a
synthetically stable medication (96). In the present
study sensational changes in the disintegration
conduct of a few definitions have been watched.
The medication definition that fizzled the
soundness test had a more than 40% decrease in
the measure of medication discharged following 3
and 6 months of security testing. It was unrealistic
to distinguish the reason for the disappointment in
disintegration of the plans, as the careful
arrangement of the details was not accessible. It is
realized that the unexpected communications
among the elements of the measurement structure
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 IAJPS 2017, 4 (12), 4253-4264 Muhammad Saood et al
occurring for a medication plan put away at high
temperature and stickiness conditions are mind
boggling and definition subordinate. (97)
The F.P.Ps might have for instance disintegrants,
which can detached its ability to swell on
maturing or on revelation to high
mugginess/temperature (98). For the details that
did not go along the USP determinations of the
disintegration test, no firm choice might be
tackled its bioavailability profile. (97)
Since numerous reports have portrayed on the
instances of trial details with an essentially
decreased in-vitro drug discharge attributes after
maturing, however offering comparable
bioavailability profiles to new definitions .Such
cases have been watched for matured
Nitrofurantoin cases (99). Conversely different
studies directed with the outcomes that
Nitrofurantioin tablet definitions upon
introduction to stretch conditions offered a
noteworthy reduction in-vitro drug discharge
profiles furthermore an impressive decrease in
their rate of retention (100). The inability to
follow the USP disintegration details might be
considered as a notice of an imminent
bioavailability issue.
The disintegration tests were skillful to separate
low quality F.P.Ps amongst the examples that had
surrendered the concoction test tests. Albeit all the
F.P.Ps showed compound corruption after
maturing yet a percentage of the details displayed
maturing reduction in their disintegration conduct
when contrasted with pioneer/standard references
brand (Axcin).This impact was high up at high
temperature and abnormal state of stickiness
proportion (40 C2/RH; 75%5%) while at
states of 25 C2/RH;60%5% it was
moderately less lively. At first 62.5%(3/5) of the
chose brands indicated disintegration profile like
the standard detailing i.e f2 esteem 50 or near 50
however upon introduction to reenacted tropical
capacity conditions, this proportion was
drastically decreased to 12.5%. This as well as
one of the brands fizzled the disintegration test
subsequent to being subjected to a dependability
test at reproduced tropical conditions which
affirms that increment in temperature and
stickiness improve the rate of synthetic response
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(102). As identified with the administrative
perspectives ,the WHO encourage a quickened
soundness test under zone IV climatic conditions
to be executed for all pharmaceutical
measurements frames made arrangements for
bringing into the worldwide pharmaceutical
market(Matthews)(101) A steadiness test is
proposed as a quality control apparatus that might
be utilized to affirm if a dose structure/definition
and the assembling process don't impact the
adequacy and wellbeing of the item under the
appropriation and capacity conditions .The
breakdown of a few details to guarantee
disintegration's standard particulars subsequent to
being subjected to a dependability test at
mimicked tropical capacity conditions guess that
the medication plans are confused for promoting
in nations with tropical atmosphere conditions, for
example, Pakistan. Standard examining and
observation of the quality and security in tropical
states of the details on business sector by the
administrative power ought to be idealistic as
method for keeping the passageway to the
business sector of pharma with
CONCLUSION:
During the collection of the samples, it was
appeared that there are huge disparity between the
price of innovator brand and their generic
equivalents. It is very important to take essential
measures aimed at to control and monitor the
quality of the medicines, available in the phrma
market. The in-vitro evaluation of 5 different
F.P.Ps of Ciprofloxacin HCl film coated tablets
available in the pharmaceutical market of Pakistan
showed that all of brands of Ciprofloxacin
satisfied the USP potency specifications and
showed evidences of satisfactory initial in-vitro
dissolution behavior. However, the dissolution
characteristics after storage at simulated tropical
conditions for 6 months, 2 of these F.P.Ps were
not acceptable. The evaluation of the
bioavailability of these formulations is optional to
expound the effect of poor dissolution on its
bioavailability
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